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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007196-17 | |||
| 00887445 |
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The study was terminated on June 25th, 2009 due to strategic decision
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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First in man study with single and multiple rising doses with SLV341
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLV341 | Drug | 5 - 1000mg once daily |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR | 1 - 28 days | |
| Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring. | 28 days |
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Inclusion Criteria healthy Exclusion Criteria not healthy
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Meuwsen | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S341.1.001 Site # | London | United Kingdom |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Drug |
|
| Interaction with Midazolam | 24 hours |